110411
D
Expired.
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing, Replicationไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆ ธ้ ธๅค็ใๅคๅถ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing, Replication. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆต่ฏๅ็ใๆ ธ้ ธๆข้
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19666
Product Code Detail
19666 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
State
Expired.
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Hologic, Inc.
Hologic
United States
็พๅฝ
10210 Genetic Center Drive, San Diego, CA 92121, United States
10210้ไผ ไธญๅฟ้ฉฑๅจๅจ, ๅฃๅฐไบๅฅ, CA 92121, ็พ
Authorised Representative (AR)
21613100
Regulatory Timeline
Registration Date
August 05, 2015
Expiry Date
November 18, 2016
Product Models
Procleix Ultrio Assay (1000-Test Kit) (301103), Procleix Ultrio Assay (5000-Test Kit) (301105), Procleix Ultrio Assay Calibrators (301106), Procleix Ultrio HBV Discriminatory Probe (301109), Procleix Ultrio HCV Discriminatory Probe (301108), Procleix Ultrio HIV-1 Discriminatory Probe (301107), Procleix Ultrio Tigris Controls (302193), Procleix Ultrio Negative Calibrator Kit (303259), Procleix Ultrio Tigris Negative Controls Kit (303258), Procleix Auto Detect Reagents Kit (301120), Procleix Oil Kit (302441), Procleix Wash Solution (303665), Procleix Buffer for Deactivation Fluid (303666)
Procleix Ultrio ๆฃๆต่ฏๅ็ (1000-ๆฃๆต่ฏๅ็) (301103), Procleix Ultrio ๆฃๆต่ฏๅ็ (5000-ๆฃๆต่ฏๅ็) (301105), Procleix Ultrio ๆฃๆตๆ กๅๅ (301106), Procleix Ultrio HBV ๅคๅซๆข้ (301109), Procleix Ultrio HCV ๅคๅซๆข้ (301108), Procleix Ultrio HIV-1 ๅคๅซๆข้ (301107), Procleix Ultrio ๅบๆ ผ้ๆฏๅฏน็
ง (302193), Procleix Ultrio ้ดๆงๆ กๅ่ฏๅ็ (303259), Procleix Ultrio ๅบๆ ผ้ๆฏ้ดๆงๅฏน็
ง่ฏๅ็ (303258), Procleix ่ชๅจๆฃๆต่ฏๅ็ (301120), Procleix ๆฒนๅฅไปถ (302441), Procleix ๆดๆถคๆถฒ (303665), ็จไบๅ็จๆถฒ็ Procleix ็ผๅฒๆถฒ (303666)